MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number ONXANE-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports, patient experienced pericardial tamponade post surgery due to increased inr.Date of surgery was (b)(6) 2018.The bleeding event occurred (b)(6) 2018 and lasted 7 days.The event was fully resolved.

Manufacturer Narrative

A review of the manufacturing records confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.A review of the available information was performed.The patient, 57 year old female, as part of the aortic post approval study, implanted with onxane-23, (b)(4)., in the aortic position on (b)(6) 2018 for congenital cardiac etiology.Bleeding event reported (b)(6) 2018 (10 days postop), "pericardial tamponade post-surgery due to increased inr [6.7]" with subsequent atrial fibrillation and resolving on february 1, 2018.The study adjudicator indicated that the event was a perioperative, non-valve related bleed due to excessive anticoagulation.Excessive bleeding after cardiopulmonary bypass is one of the most frequently reported complications of cardiac operations [hartstein].The exact cause/source of the perioperative bleeding cannot be ascertained however the event was complicated by the elevated inr due to excessive anticoagulation.The leaking blood surrounding the heart likely contributed to the arrhythmia reported.Bleeding and cardiac arrhythmia are recognized potential complications for mechanical valve recipients [instructions for use) and are not uncommon during open heart surgery.Root cause for this event is excessive anticoagulation in the perioperative period.Bleeding and arrhythmias are known potential complications following aortic valve replacement surgery.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.No further action is warranted at this time.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to initial reports, patient experienced pericardial tamponade post surgery due to increased inr.Date of surgery was (b)(6) 2018.The bleeding event occurred (b)(6) 2018 and lasted 7 days.The event was fully resolved.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8068978
• MDR Text Key: 127075294
• Report Number: 1649833-2018-00165
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/17/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR